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Case Report Form Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC)

- 2/12/16 - 1 form, 12 itemgroups, 226 items, 1 language
Itemgroups: Visit 1: Screening visit and informed consent, Medical history of first cancer diagnosis, Surgery, Prior treatment, Medical history, Vital signs and physical examination, Laboratory results, Blood cell count, CTCAE Staging/Preexisting symptoms, Inclusion criteria, Exclusion criteria, Inclusion of Patient
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

Concomitant medication Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC) Concomitant medication

- 2/17/16 - 1 form, 1 itemgroup, 11 items, 1 language
Itemgroup: Concomitant Medication Form
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

Adverse Events Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC) Adverse Events

- 2/17/16 - 1 form, 1 itemgroup, 15 items, 1 language
Itemgroup: Adverse Events Form
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

Visit 8 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC) Visit 8

- 2/16/16 - 1 form, 5 itemgroups, 110 items, 1 language
Itemgroups: Visit 8: Day 21 post-OP, Vital signs and physical examination, Laboratory results, Inquiry of dose limiting toxicity, Confirmation of correctness
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

Visit 7 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC) Visit 7

- 2/15/16 - 1 form, 4 itemgroups, 79 items, 1 language
Itemgroups: Visit 7:Day 14 post-surgery, Vital signs, concomitant medication and CTCAE, Laboratory results, Confirmation of correctness
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

Visit 6 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC) Visit 6

- 2/15/16 - 1 form, 4 itemgroups, 79 items, 1 language
Itemgroups: Visit 6:Day 7 post-surgery, Vital signs, concomitant medication and CTCAE, Laboratory results, Confirmation of correctness
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

Visit 5 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC) Visit 5

- 2/15/16 - 1 form, 4 itemgroups, 88 items, 1 language
Itemgroups: Visit 5:Day 5 post-surgery, Vital signs, concomitant medication and CTCAE, Laboratory results, Confirmation of correctness
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

Visit 4 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC) Visit 4

- 2/12/16 - 1 form, 4 itemgroups, 88 items, 1 language
Itemgroups: Visit 4:Day 3 post-surgery, Vital signs, concomitant medication and CTCAE, Laboratory results, Confirmation of correctness
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

Visit 3 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC) Visit 3

- 2/12/16 - 1 form, 4 itemgroups, 88 items, 1 language
Itemgroups: Visit 3:Day 1 post-surgery, Vital signs, concomitant medication and CTCAE, Laboratory results, Confirmation of correctness
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

Visit 2 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case report form (HIPEC) Visit 2

- 2/11/16 - 1 form, 5 itemgroups, 56 items, 1 language
Itemgroups: Patient Identification, Debulking surgery, HIPEC, Pharmacokinetics, Confirmation of correctness
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

Visit 12 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC) Visit 12

- 2/17/16 - 1 form, 5 itemgroups, 48 items, 1 language
Itemgroups: Visit 12: Fourth cycle of post-OP Chemotherapy, Status of Patient and recording of CTCAE, Postoperative intravenous chemotherapy, Course of chemotherapy cycle, Confirmation of correctness
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

Visit 14 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC) Visit 14

- 2/17/16 - 1 form, 5 itemgroups, 48 items, 1 language
Itemgroups: Visit 14: Sixth cycle of post-OP Chemotherapy, Status of Patient and recording of CTCAE, Postoperative intravenous chemotherapy, Course of chemotherapy cycle, Confirmation of correctness
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

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